—#95801

Product

ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes) CC-04100, FS-04510, NS-04100 and PW-04100. Cardiovascular catheterization kit

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K810675
Affected lot / code info: CC-04100 Lot Numbers: RF0019630, RF0035146, RF0062164, RF0063964, RF4121260, RF5012171, RF5022620, RF5022694, RF5022936, RF5023056, RF5043795, RF5044244, RF5054841, RF5060136, RF5072938, RF5083080, RF5084506, RF5095700, RF5106236, RF5118583, RF6012260, RF6022847, RF6033756, RF6034434, RF6035286, RF6057003, RF6068210, RF6070336, RF6080902, RF6081546, RF6093300, RF6104481, RF6115675, RF6116613, RF6127345, RF6127983, RF7018330, RF7020221, RF7032233, RF7054012, RF7054686, RF7065398, RF7076855, RF7077581, RF7088648, RF7089293, RF7090478, RF7101417, RF7112432, RF7113766, RF7124960, RF8015963, RF8020094, RF8029171, RF8031984, RF8033220, RF8044241, RF8045487, RF8056874, RF8057384, RF8068362, RF8071384, RF8083492, RF8085126, RF8096691, RF8109018, RF8110511, RF8110923, RF8123490, RF9015797, RF9027384, RF9028781, RF9030798, RF9044347, RF9056860, RF9057865, RF9060300, RF9071990, RF9101135, RF9112313, RF9112770, RF9114303 and RF9125231. FS-04510 Lot Numbers: RF0020943, RF0033155, RF0059261, RF0062162, RF0075661, RF8033219, RF8045501, RF8070634, RF8119793, RF8124055, RF9030633, RF9068315, RF9071039, RF9085981, RF9101233 and RF9126921. NS-04100 Lot Numbers: RF0021271, RF0035169, RF0059455, RF0062166, RF0076519, RF0087520, RF5012173, RF5012263, RF5022525, RF5022640, RF5022884, RF5033202, RF5043960, RF5044137, RF5044415, RF5054655, RF5055028, RF5060314, RF5072320, RF5084106, RF5095841, RF5106237, RF5107230, RF5118615, RF6011424, RF6012258, RF6022392, RF6033757, RF6034356, RF6045750, RF6057353, RF6057883, RF6068372, RF6068635, RF6070561, RF6079358, RF6080954, RF6081473, RF6082032, RF6093231, RF6104147, RF6116038, RF6116779, RF7018345, RF7020079, RF7029684, RF7031136, RF7031694, RF7042757, RF7043349, RF7054836, RF7066014, RF7066675, RF7077586, RF7088649, RF7089181, RF7090486, RF7101953, RF7102163, RF8015969, RF8016893, RF8029175, RF8031766, RF8033221, RF8044245, RF8045307, RF8057233, RF8068375, RF8072081, RF8083722, RF8097203, RF8107887, RF8111833, RF811833, RF9014775, RF9027307, RF9042699, RF9068374, RF9085995, RF9101133, RF9112853, RF9114302 and RF9125236. PW-04100 Lot Numbers: RF8029429, RF8031774, RF8043868 and RF8057234.

Why it was recalled

Sterility may be compromised.

Root cause (FDA determination)

Other

Action the firm took

Arrow International, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated October 29, 2010, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customer. Customers were instructed to quarantine the product. If they had no affected product in stock, check the appropriate box on the Recall Acknowledgement & Stock Status Form and fax the form to Arrow's Customer Service fax number 800-343-2935. If they had affected stock, immediately quarantine the product and contact Arrow Customer Service at 800-523-8446 for a Return Authorization Number. If customers wished to return product for replacement, they were to consult their sales representative or Arrow Customer Service for information on product availability, substitutability, and lead times. Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the compoleted form to Arrow, Fax number 800-343-2935, Attn: Customer Service. Return any affected product freight collect, along with the original completed Recall Acknowledgement & Stock Status Form to: Arrow International, Inc. 312 Commerce Place Aheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. For any questions regarding this recall call 800-523-8446.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: Worldwide Distribution -- United States - all 50 States, and the countries of Canada, South America, China, South Africa, Australia, Puerto Rico, Philippines, Singapore, South Korea, New Zealand, Mexico, Japan, India, Indonesia, Bahamas, Taiwan, Thailand, Finland, France, Cyprus, Czech Republic, Belgium, Germany, Ireland, Italy, Latvia, Netherlands, Poland, Slovakia, Spain, Bahamas, Costa Rico, Dominican Republic, Ecuador, Guatamala and the United Kingdom.

Timeline

Recall initiated: 2010-10-29
Posted by FDA: 2011-02-17
Terminated: 2012-09-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95801. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.